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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05446350
Other study ID # RC31/20/0340
Secondary ID 2020-A02707-32ST
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date September 2025

Study information

Verified date August 2022
Source University Hospital, Toulouse
Contact Mathieu MARX, PU-PH
Phone +33 (0)5 61 77 77 04
Email marx.m@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to further develop tACS as a tool to improve speech perception, by manipulation of brain-speech synchronisation ("entrainment"), thereby transforming a promising approach into a technique that can benefit to society on a large scale.


Description:

Neural oscillations align their phase to the rhythm of speech. This phenomenon is termed neural entrainment and associated with successful speech comprehension. Importantly, we have demonstrated that transcranial alternating current stimulation (tACS) can be used to manipulate how neural activity aligns to speech rhythm, leading to changes in speech perception. The aim of Experiment 1 is to understand how tACS operates on the neural level. This aim will be reached by testing whether tACS produces rhythmic electroencephalography (EEG) responses that outlast the stimulation, indicating an involvement of endogenous oscillatory activity. The aim of Experiment 2 is to increase efficacy of tACS and, consequently, its potential to play an important role in research and everyday life applications. This aim will be reached by using brain imaging (fMRI) to predict optimal stimulation protocols for individual participants. The aim of Experiment 3 is to reveal how tACS can boost speech perception in a multi-speaker scenario. This aim will be reached by using tACS to enhance attended speech or suppress distracting speech, and by comparing these two approaches in their efficacy to boost speech perception. The aim of Experiment 4 is to combine established techniques to create novel opportunities to improve speech perception. This aim will be reached by using neurofeedback to teach participants to enhance their own neural entrainment, applying tACS to support them in this process.


Recruitment information / eligibility

Status Recruiting
Enrollment 126
Est. completion date September 2025
Est. primary completion date September 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Subject aged between 18 and 50 years old - informed written consent - Absence of pro-epileptogenic drugs - Absence of visual or hearing impairment incompatible with participation in the study Exclusion Criteria: - Pregnant or breastfeeding women, - Persons protected by law adults under guardianship or curatorship - Persons not affiliated to a Social Security scheme - Subjects with progressive psychiatric or neurological pathology - Subjects with a contraindication to tCS or MRI (history of epilepsy, severe head injury or brain/spinal cord surgery, cardiac pacemaker/defibrillator, implanted equipment activated by electrical, magnetic or mechanical system, hemostatic clip carriers of intracerebral aneurysms or carotid arteries, orthopedic implant carriers, claustrophobic, pregnancy).

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
transcranial alternating current stimulation (tACS)
transcranial alternating current stimulation (tACS) used to manipulate how neural activity aligns to speech rhythm, leading to changes in speech perception
electroencephalography (EEG)
analyse rhythmic electroencephalography responses that outlast the stimulation
brain imaging (fMRI)
Using brain imaging (fMRI) to predict optimal stimulation protocols for individual participants
electroencephalography (EEG) with neurofeedback
Using neurofeedback to teach participants to enhance their own neural entrainment

Locations

Country Name City State
France CHU Toulouse Toulouse

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Toulouse Centre National de la Recherche Scientifique, France

Country where clinical trial is conducted

France, 

References & Publications (3)

van Bree S, Sohoglu E, Davis MH, Zoefel B. Sustained neural rhythms reveal endogenous oscillations supporting speech perception. PLoS Biol. 2021 Feb 26;19(2):e3001142. doi: 10.1371/journal.pbio.3001142. eCollection 2021 Feb. — View Citation

Zoefel B, Allard I, Anil M, Davis MH. Perception of Rhythmic Speech Is Modulated by Focal Bilateral Transcranial Alternating Current Stimulation. J Cogn Neurosci. 2020 Feb;32(2):226-240. doi: 10.1162/jocn_a_01490. Epub 2019 Oct 29. — View Citation

Zoefel B, Davis MH, Valente G, Riecke L. How to test for phasic modulation of neural and behavioural responses. Neuroimage. 2019 Nov 15;202:116175. doi: 10.1016/j.neuroimage.2019.116175. Epub 2019 Sep 6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary correctly identified words percentage of correctly identified words during or after tACS who will permit to evaluate efficacy of tACS to modulate speech perception and neural responses in different experimental conditions (involving electrophysiological, brain imaging, and perceptual measures) Day 1
Secondary correctly identified words with different modality percentage of correctly identified words during or after tACS between different modality day 1
Secondary oscillatory activities measurement of oscillatory activities resulting from electrical stimulation: (frequency, power, and phase, latency) on the scalp and at the level of the sources and their synchronization with during or after tACS Day 1
Secondary neural activity measurement of neural activity that results from electrical stimulation: fMRI (BOLD response) during or after tACS Day 1
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